The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
The PharmaDx Director, Quality and Regulatory Affairs is responsible for developing and implementing the quality and regulatory strategies for the PharmaDx Department. The PharmaDx Director, Quality and Regulatory Affairs supports the establishment and execution of sustainable processes, assures informed relationships with internal and external stakeholders, and delivers strategic outcomes in the areas of quality and regulatory affairs. Acts as the liaison with external regulatory colleagues and provides regulatory guidance to ensure achievement of strategic goals. Provides critical guidance for change management and audit processes for PharmaDx projects.
This position is also responsible for ensuring ongoing compliance to applicable regulations and standards (e.g.: ISO, FDA, IVDD, IVDR, CAP/CLIA, GMP, international regulatory standards, etc.) and ensuring the quality of the manufacturing processes and clinical trials studies performed by the PharmaDx group. This position reports to the PharmaDx Executive Director and works with limited supervision and wide latitude for independent judgment and decision-making.
This position can be remote.
Bachelor’s degree in Business Management, Project Management, Medical Laboratory Science, Biology, Chemistry or related field, and at least 12 years of laboratory industry experience OR Master’s degree in Regulatory Affairs plus a Regulatory Affairs Certification and 8 years of laboratory industry experience
Advanced knowledge of CAP/CLIA, ISO, FDA, IVDD, IVDR, GMP, and/or international regulatory standards
Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society
Internal Number: PHARM12207
About ARUP Laboratories
ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. With more than 4,500 employees, ARUP offers in excess of 3,000 tests and test combinations, ranging from routine screening tests to highly esoteric molecular and genetic assays.
ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient’s life. We never forget that there is a patient behind every specimen we receive.
We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.